Conditions

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

This study is for a continuing treatment for high risk neuroblastoma. This study is called a clinical trial. A clinical trial is a research study involving treatment of a disease in human patients. This study is organized by Children’s Oncology Group (COG). COG is an international research group that conducts clinical trials for children with cancer. More than 200 hospitals in North America, Australia, New Zealand, and Europe are members of COG. It is common to enroll children and adolescents with cancer in a clinical trial that seeks to improve cancer treatment over time. Clinical trials include only people who choose to take part.

Participation Guidelines

Age:

Up to 30 Years

Gender:

Both

Eligibility Criteria

Inclusion Criteria:

Diagnosis of neuroblastoma

Categorized as high risk at diagnosis exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/ or relapsed) to high risk neuroblastoma are also eligible

Meets all of the following criteria:

Patients must have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy

Radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor

Completed frontline therapies, examples of such therapy includes:

Following treatment per COG-A3973 protocol

Following treatment per POG-9340-42

Following treatment per CCG-3891

Following treatment on NANT-2001-02

Enrollment on or following treatment per COG-ANBL02P1 protocol

Enrollment on or following treatment per ANBL07P1

Tandem transplant patients are eligible

Following enrollment and treatment on or per COG-ANBL0532

Following treatment per POG-9640 protocol

Following treatment per COG-ANBL00P1 protocol

Following treatment per CHP 594 or DFCI 34-DAT

Other frontline therapy with permission from study chairs

Must meet the International Neuroblastoma Response Criteria (INRC)for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:

No more than 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy

Patient who have no tumor seen on the prior bone marrow, and then have = 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible

No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT except for the rare occasions as noted below for tandem ASCT patients, this will be the date of the FIRST stem cell infusion exception: For those who are initially diagnosed as non-high risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma, the 12 months restriction should start from the date of induction therapy for high risk neuroblastoma (not from the initial induction therapy for non-high risk disease), to the date of ASCT

Prior to enrollment on ANBL0032, a determination of mandatory disease staging must be performed (tumor imaging studies including CT or MRI, MIBG scan, bone marrow aspiration &amp biopsy) this disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before enrollment

For those with residual disease before radiotherapy, re-evaluation of irradiated residual tumors is preferably performed at the earliest 5 days after completing radiotherapy patients with residual disease are eligible biopsy is not required patients who have biopsy proven residual disease after ASCT will be enrolled on Stratum 07

Patients must not have progressive disease at the time of study enrollment except for protocol specified bone marrow response these patients will be enrolled on Stratum 07

Patients must be enrolled before treatment begins the date protocol therapy is projected to start must be no later than ten (10) calendar days after the date of study enrollment

Patients should be enrolled preferably between Day 56 and Day 85 after PBSC infusion (day from 2nd stem cell infusion for tandem transplant) patients must be enrolled no later than Day 100 after PBSC infusion enrollment must occur after completion of radiotherapy, and after completion of tumor assessment post-ASCT and radiotherapy informed consent should be obtained within 3 weeks pre-ASCT up to the time of registration

All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated